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541848

McKenna Labs Inc — FEI 3003449422

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 15, 2008
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fullerton, CA (United States)

Facility

Other inspections at this facility

  • 1261255 (VAI Thu Feb 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1120409 (VAI Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016911 (VAI Wed Jul 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 702867 (NAI Tue Dec 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
436721 CFR 211.188(b)(13)Examinations for correct labeling
437121 CFR 211.188(b)(9)Description of containers and closures
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies